UMIN-CTR Clinical Trial

Basic information
Public title	Study on the influence of difference in joystick of mobility assist device on usability in healthy young, elderly and patients with central nervous system disorders.
Acronym	Study on Joystick usability of mobility assist device.
Scientific Title	Study on the influence of difference in joystick of mobility assist device on usability in healthy young, elderly and patients with central nervous system disorders.
Scientific Title:Acronym	Study on Joystick usability of mobility assist device.
Region	Japan

Condition
Condition	Healthy young, elderly and patients with central nervous system disorders.
Classification by specialty	Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To test whether difference in usability depending on the difference of some joystick types in mobility assistive device.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Subjective operability
Key secondary outcomes	Speed, Accuracy, Body function including finger dexterity, Cognitive function, Activities of daily living

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Participants uses some joysticks to drive on a predetermined course, and to reply ease of operation.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	1. The subjects who have given written informed consent by themselves. 2. The subjects who can sit independently. 3. The subjects who can transfer between a bed and a wheelchair. 4. The patients with supra-tentorial lesion. 5. The patients with hemiplegia. 6. The patients without apparent paralysis in the unaffected limbs.
Key exclusion criteria	1. The subjects whose general condition was poor. 2. The subjects having difficulties in understanding the study design, providing consent to, or participating in the study due to cognitive impairment, aphasia or dementia. 3. The subjects presenting severe joint deformation including degenerative deformity. 4. The subjects who are decided by a doctor or investigator as being inappropriate for entry into the present study.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Eiichi Middle name Last name Saitoh
Organization	Fujita Health University, School of Medicine
Division name	Department of Rehabilitation Medicine I
Zip code	470-1192
Address	1-98, Dengakugakubo, Kutsukake, Toyoake, Aichi, Japan
TEL	0562-93-2167
Email	rehabmed@fujita-hu.ac.jp

Public contact
Name of contact person	1st name Soichiro Middle name Last name Koyama
Organization	Fujita Health University, School of Health Sciences
Division name	Faculty of Rehabilitation
Zip code	470-1192
Address	1-98, Dengakugakubo, Kutsukake, Toyoake, Aichi, Japan
TEL	0562-93-9000
Homepage URL
Email	koyamas@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University
Institute
Department

Funding Source
Organization	Fujita Health University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board of Fujita Health University
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake-shi, Aichi
Tel	0562-93-2865
Email	f-irb@fujita-hu.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	藤田医科大学（愛知県） Fujita Health University 藤田医科大学病院（愛知県）Fujita Health University Hospital

Other administrative information
Date of disclosure of the study information	2019 Year 04 Month 01 Day

Related information
URL releasing protocol	https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000041175
Publication of results	Unpublished

Result
URL related to results and publications	https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000041175
Number of participants that the trial has enrolled	44
Results	Despite no significant differences in the primary outcome between joysticks, the I-shaped joystick with rounded tips (neutral grip) was ranked higher than the others. MT did not differ between joysticks, but DA was higher for the thin-columnar I-shaped joystick (pinch grip) than for the U- and T-shaped joysticks (pronated grip). MT and DA scores for young adults were significantly better than those for older adults. Further studies should be conducted to clarify possible factors related to EPW operability.
Results date posted	2022 Year 04 Month 06 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Forty-four healthy adults (22 young and 22 old).
Participant flow	All patients were enrolled.
Adverse events	No adverse events occurred in this study.
Outcome measures	Subjective ranking
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 02 Month 01 Day
Date of IRB	2018 Year 05 Month 15 Day
Anticipated trial start date	2018 Year 10 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 03 Month 29 Day
Last modified on	2022 Year 07 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041175